Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study

• ClinicalTrials.gov Identifier: NCT03635424
• Recruitment Status: Active, not recruiting
• First Posted: August 17, 2018
• Results First Posted: December 21, 2020
• Last Update Posted: May 2, 2024
• Sponsor: Medtronic Cardiovascular
• Information provided by (Responsible Party): Medtronic Cardiovascular

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Bicuspid Aortic Valve
• Intervention: Device: Medtronic TAVR Systems
• Enrollment: 150

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Medtronic TAVR Systems
Arm/Group Description	Treatment with Medtronic Evolut PRO and Evolut R systems
Period Title: Overall Study
Started	150
Completed	147
Not Completed	3
Reason Not Completed
Adverse Event	1
Death	1
Device not implanted	1

Baseline Characteristics

Arm/Group Title		Medtronic TAVR Systems
Arm/Group Description		Treatment with Medtronic Evolut PRO and Evolut R systems
Overall Number of Baseline Participants		150
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years of age
	Number Analyzed	150 participants
		70.3 (5.5)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	150 participants
	Female	72 48.0%
	Male	78 52.0%
Race and Ethnicity Not Collected [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	150 participants
		150
Body Surface Area (BSA) [1]; Mean (Standard Deviation); Unit of measure: M^2
	Number Analyzed	150 participants
		1.9 (0.2)
		[1] Measure Description: Calculated surface area of the human body in m^2
Society of Thoracic Surgeons (STS) Score [1]; Mean (Standard Deviation); Unit of measure: % risk of mortality
	Number Analyzed	150 participants
		1.4 (0.6)
		[1] Measure Description: STS score of predicted risk of 30-day mortality
New York Heart Association (NYHA) Classification [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	150 participants
	NYHA Class I	3 2.0%
	NYHA Class II	106 70.7%
	NYHA Class III	40 26.7%
	NYHA Class IV	1 0.7%
		[1] Measure Description: NYHA Classification: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.

Outcome Measures

1. Primary Outcome

Title	Safety: Percent of Participants With All-Cause Mortality or Disabling Stroke Rate at 30 Days Post-procedure.
Description	Rate of of all-cause mortality or disabling stroke rate at 30 days
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Attempted Implant Set

Arm/Group Title	Medtronic TAVR Systems
Arm/Group Description:	Treatment with Medtronic Evolut PRO and Evolut R systems
Overall Number of Participants Analyzed	150
Measure Type: Number; Unit of Measure: Percent of participants (K-M rate)
	1.3

2. Primary Outcome

Title	Efficacy: Percent of Participants Who Meet All Device Success Criteria at 30 Days Post-procedure.
Description	Device success rate, defined as: Absence of procedural mortality, AND; Correct positioning of a single prosthetic heart valve into the proper anatomical location, AND; Absence of moderate or severe total prosthetic valve regurgitation (at 18 hours to 7 days)
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

Implanted Set

Arm/Group Title	Medtronic TAVR Systems
Arm/Group Description:	Treatment with Medtronic Evolut PRO and Evolut R systems
Overall Number of Participants Analyzed	148
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percent of participants
	95.9; (91.3 to 98.5)

3. Secondary Outcome

Title	All-Cause Mortality Rate
Description	Rate of all cause mortality
Time Frame	1 year and annually through 10 years

Outcome Measure Data Not Reported

4. Secondary Outcome

Title	All Stroke (Disabling and Non-Disabling) Rate
Description	Rate of disabling and non-disabling strokes
Time Frame	1 year and annually through 10 years

Outcome Measure Data Not Reported

5. Secondary Outcome

Title	Percent of Participants With New Permanent Pacemaker Implantation at 30 Days Post-procedure.
Description	Rate of new permanent pacemaker implantation at 30 days post-procedure (excludes patients with pre-existing pacemaker at baseline)
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Attempted Implant set

Arm/Group Title	Medtronic TAVR Systems
Arm/Group Description:	Treatment with Medtronic Evolut PRO and Evolut R systems
Overall Number of Participants Analyzed	150
Measure Type: Number; Unit of Measure: Percent of participants (K-M rate)
	15.1

6. Secondary Outcome

Title	Percent of Participants Who Experience a Myocardial Infarction at 30 Days Post-procedure.
Description	The rate of myocardial infarction at 30 days
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Attempted Implant set

Arm/Group Title	Medtronic TAVR Systems
Arm/Group Description:	Treatment with Medtronic Evolut PRO and Evolut R systems
Overall Number of Participants Analyzed	150
Measure Type: Number; Unit of Measure: Percent of participants (K-M rate)
Myocardial infarction	0.7
Peri-procedural myocarial infarction	0.0
Spontaneous myocardial infarction	0.7

7. Secondary Outcome

Title	Percent of Participants With a Life-Threatening Bleeding Event at 30 Days Post-procedure.
Description	Rate of life-threatening (or disabling) bleeding at 30 days
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Attempted Implant set

Arm/Group Title	Medtronic TAVR Systems
Arm/Group Description:	Treatment with Medtronic Evolut PRO and Evolut R systems
Overall Number of Participants Analyzed	150
Measure Type: Number; Unit of Measure: Percent of participants (K-M rate)
	4.0

8. Secondary Outcome

Title	Percent of Participants With Prosthetic Valve Endocarditis at 30 Days Post-procedure.
Description	Rate of prosthetic valve endocarditis at 30 days
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Attempted Implant set

Arm/Group Title	Medtronic TAVR Systems
Arm/Group Description:	Treatment with Medtronic Evolut PRO and Evolut R systems
Overall Number of Participants Analyzed	150
Measure Type: Number; Unit of Measure: Percent of participants (K-M rate)
	0.0

9. Secondary Outcome

Title	Percent of Participant With Prosthetic Valve Thrombosis at 30 Days Post-procedure.
Description	Rate of prosthetic valve thrombosis at 30 days
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Attempted Implant set

Arm/Group Title	Medtronic TAVR Systems
Arm/Group Description:	Treatment with Medtronic Evolut PRO and Evolut R systems
Overall Number of Participants Analyzed	150
Measure Type: Number; Unit of Measure: Percent of participants (K-M rate)
	0.7

10. Secondary Outcome

Title	Percent pf Participants With Valve-Related Dysfunction Requiring Repeat Procedure at 30 Days Post-procedure.
Description	Rate of valve-related dysfunction requiring repeat procedure at 30 days
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Attempted Implant set

Arm/Group Title	Medtronic TAVR Systems
Arm/Group Description:	Treatment with Medtronic Evolut PRO and Evolut R systems
Overall Number of Participants Analyzed	150
Measure Type: Number; Unit of Measure: Percent of participants (K-M rate)
	0.0

11. Secondary Outcome

Title	Percent of Participants With a Repeat Hospitalization for Aortic Valve Disease at 30 Days Post-procedure.
Description	Rate of repeat hospitalization for aortic valve disease at 30 days
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Attempted Implant set

Arm/Group Title	Medtronic TAVR Systems
Arm/Group Description:	Treatment with Medtronic Evolut PRO and Evolut R systems
Overall Number of Participants Analyzed	150
Measure Type: Number; Unit of Measure: Percent of participants (K-M rate)
	4.0

12. Secondary Outcome

Title	Percent of Participants With a Repeat Hospitalization for Ascending Aorta Disease at 30 Days Post-procedure.
Description	Rate of repeat hospitalization for ascending aorta disease at 30 days
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Attempted Implant set

Arm/Group Title	Medtronic TAVR Systems
Arm/Group Description:	Treatment with Medtronic Evolut PRO and Evolut R systems
Overall Number of Participants Analyzed	150
Measure Type: Number; Unit of Measure: Percent of participants (K-M rate)
	0.0

13. Secondary Outcome

Title	Hemodynamic Performance Metrics by Doppler Echocardiography: Mean Aortic Gradient Reported as Mean Average at Baseline and 30 Days
Description	Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Implanted set

Arm/Group Title	Medtronic TAVR Systems
Arm/Group Description:	Treatment with Medtronic Evolut PRO and Evolut R systems
Overall Number of Participants Analyzed	148
Mean (Standard Deviation); Unit of Measure: mmHg
Baseline	48.01 (16.09)
30 Day	7.58 (3.69)

14. Secondary Outcome

Title	Hemodynamic Performance Metrics by Doppler Echocardiography: Effective Orifice Area Reported as Mean Average at Baseline and 30 Days.
Description	Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Implanted set

Arm/Group Title	Medtronic TAVR Systems
Arm/Group Description:	Treatment with Medtronic Evolut PRO and Evolut R systems
Overall Number of Participants Analyzed	148
Mean (Standard Deviation); Unit of Measure: cm^2
Baseline	0.81 (0.23)
30 Day	2.28 (0.73)

15. Secondary Outcome

Title	Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Total Prosthetic Valve Regurgitation at Baseline and 30 Days
Description	Reporting of prosthetic valve hemodynamic performance by degree of total prosthetic valve regurgitation at 30 days post-procedure
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Implanted set

Arm/Group Title	Medtronic TAVR Systems
Arm/Group Description:	Treatment with Medtronic Evolut PRO and Evolut R systems
Overall Number of Participants Analyzed	148
Measure Type: Number; Unit of Measure: Percentage of participants
Baseline: None	30.4
Baseline: Trace	24.3
Baseline: Mild/Mild to Moderate	42.6
Baseline: Moderate/Moderate to Severe	2.7
Baseline: Severe	0.0
Baseline: >=Moderate	2.7
30 Day: None	34.2
30 Day: Trace	25.3
30 Day: Mild/Mild to Moderate	40.4
30 Day: Moderate/Moderate to Severe	0.0
30 Day: Severe	0.0
30 Day: >=Moderate	0.0

16. Secondary Outcome

Title	Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Paravalvular Prosthetic Regurgitation at 30 Days
Description	Reporting of prosthetic valve hemodynamic performance by degree of paravalvular regurgitation at 30 days post-procedure
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Implanted set

Arm/Group Title	Medtronic TAVR Systems
Arm/Group Description:	Treatment with Medtronic Evolut PRO and Evolut R systems
Overall Number of Participants Analyzed	148
Measure Type: Number; Unit of Measure: Percentage of participants
30 Day: None	36.1
30 Day: Trace	23.6
30 Day: Mild/Mild to Moderate	40.3
30 Day: Moderate/Moderate to Severe	0.0
30 Day: Severe	0.0
30 Day: >=Moderate	0.0

17. Secondary Outcome

Title	Hemodynamic Performance Metrics by Doppler Echocardiography: Percent of Participants With Degrees of Transvalvular Prosthetic Regurgitation at 30 Days
Description	Reporting of prosthetic valve hemodynamic performance by degree of transvalvular regurgitation at 30 days post-procedure
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Implanted set

Arm/Group Title	Medtronic TAVR Systems
Arm/Group Description:	Treatment with Medtronic Evolut PRO and Evolut R systems
Overall Number of Participants Analyzed	148
Measure Type: Number; Unit of Measure: Percentage of participants
30 Day: None	95.1
30 Day: Trace	4.9
30 Day: Mild/Mild to Moderate	0.0
30 Day: Moderate/Moderate to Severe	0.0
30 Day: Severe	0.0
30 Day: >=Moderate	0.0

18. Secondary Outcome

Title	New York Heart Association (NYHA) Functional Classification at Baseline and 30 Days
Description	Reporting of NYHA classification change from baseline to 30 days NYHA Classification criteria: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Attempted Implant set

Arm/Group Title	Medtronic TAVR Systems
Arm/Group Description:	Treatment with Medtronic Evolut PRO and Evolut R systems
Overall Number of Participants Analyzed	147
Measure Type: Count of Participants; Unit of Measure: Participants
30 day - Improved	121 82.3%
30 day - No Change	23 15.6%
30 day - Worsened	2 1.4%
30 day - Died	1 0.7%

19. Secondary Outcome

Title	Change in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy (KCCQ) Instrument at Baseline and 30 Days
Description	QoL overall summary (all domains below) and clinical summary (physical function and symptoms only) scores and change in summary scores from baseline using the following measures: • KCCQ: Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Attempted Implant set

Arm/Group Title	Medtronic TAVR Systems
Arm/Group Description:	Treatment with Medtronic Evolut PRO and Evolut R systems
Overall Number of Participants Analyzed	150
Mean (Standard Deviation); Unit of Measure: Score on a scale
Baseline KCCQ - Overall	68.5 (19.6)
Baseline KCCQ - Clinical	73.7 (20.3)
30 day KCCQ - Overall	90.3 (12.8)
30 day KCCQ - Clinical	91.3 (12.5)
30 day change from baseline KCCQ - Overall	21.6 (17.6)
30 day change from baseline KCCQ - Clinical	17.6 (17.7)

20. Secondary Outcome

Title	Health-related Quality of Life (QoL) as Assessed by European QoL (EQ-5D) at Baseline and 30 Days.
Description	QoL summary scores and change from baseline using the following measures: • EQ-5D: Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Attempted Implant set

Arm/Group Title	Medtronic TAVR Systems
Arm/Group Description:	Treatment with Medtronic Evolut PRO and Evolut R systems
Overall Number of Participants Analyzed	150
Mean (Standard Deviation); Unit of Measure: Score on a scale
Baseline EQ-5D Index Score	0.8 (0.1)
30 day EQ-5D Index Score	0.9 (0.1)
30 day change from baseline EQ-5D Index Score	0.1 (0.1)

Adverse Events

Time Frame	Adverse events (AEs) were collected from study enrollment through the 2 year follow-up visit. Adverse event data are currently available and reported for up to 30 days post-procedure.
Adverse Event Reporting Description	All new or worsening AEs will be collected through 2 years. After 2 years only serious and device-related events will be collected.
Arm/Group Title	Medtronic TAVR Systems
Arm/Group Description	Treatment with Medtronic Evolut PRO and Evolut R systems
All-Cause Mortality
	Medtronic TAVR Systems
	Affected / at Risk (%)
Total	1/150 (0.67%)
Serious Adverse Events
	Medtronic TAVR Systems
	Affected / at Risk (%)	# Events
Total	57/150 (38.00%)
Blood and lymphatic system disorders
Anemia †	1/150 (0.67%)	1
Heparin-Induced Thrombocytopenia †	1/150 (0.67%)	1
Cardiac disorders
Acute Myocardial Infarction †	1/150 (0.67%)	1
Atrial Fibrillation †	4/150 (2.67%)	4
Atrial Flutter †	1/150 (0.67%)	1
Atrioventricular Block †	2/150 (1.33%)	2
Atrioventricular Block Complete †	13/150 (8.67%)	13
Atrioventricular Block Second Degree †	2/150 (1.33%)	2
Bradycardia †	2/150 (1.33%)	2
Bundle Branch Block Left †	5/150 (3.33%)	5
Bundle Branch Block Right †	1/150 (0.67%)	1
Cardiac Failure Congestive †	2/150 (1.33%)	2
Cardiomyopathy †	1/150 (0.67%)	1
Conduction Disorder †	1/150 (0.67%)	1
Coronary Artery Occlusion †	1/150 (0.67%)	1
Mitral Valve Incompetence †	1/150 (0.67%)	1
Pulseless Electrical Activity †	1/150 (0.67%)	1
Sinus Bradycardia †	1/150 (0.67%)	1
Tachycardia †	1/150 (0.67%)	1
Congenital, familial and genetic disorders
Hemangioma Congenital †	1/150 (0.67%)	1
Eye disorders
Retinal Artery Occlusion †	1/150 (0.67%)	1
Visual Impairment †	1/150 (0.67%)	1
Gastrointestinal disorders
Gastrointestinal Hemorrhage †	2/150 (1.33%)	2
General disorders
Chest Discomfort †	1/150 (0.67%)	1
Chest Pain †	1/150 (0.67%)	1
Device Embolization †	1/150 (0.67%)	1
Non-Cardiac Chest Pain †	1/150 (0.67%)	1
Hepatobiliary disorders
Cholecystitis †	1/150 (0.67%)	1
Infections and infestations
Pneumonia Klebsiella †	1/150 (0.67%)	1
Respiratory Tract Infection †	1/150 (0.67%)	1
Urinary Tract Infection †	1/150 (0.67%)	1
Injury, poisoning and procedural complications
Device Deployment Issue †	1/150 (0.67%)	1
Vascular Access Site Complication †	1/150 (0.67%)	1
Vascular Pseudoaneurysm †	1/150 (0.67%)	1
Metabolism and nutrition disorders
Fluid Overload †	2/150 (1.33%)	2
Hypocalcemia †	1/150 (0.67%)	1
Hypokalemia †	1/150 (0.67%)	1
Nervous system disorders
Cerebrovascular Accident †	1/150 (0.67%)	1
Embolic Stroke †	2/150 (1.33%)	2
Headache †	1/150 (0.67%)	1
Presyncope †	2/150 (1.33%)	2
Syncope †	1/150 (0.67%)	1
Transient Ischaemic Attack †	1/150 (0.67%)	1
Product Issues
Device Leakage †	4/150 (2.67%)	4
Device Malfunction †	1/150 (0.67%)	1
Reproductive system and breast disorders
Acute Pulmonary Edema †	1/150 (0.67%)	1
Acute Respiratory Failure †	1/150 (0.67%)	1
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema †	1/150 (0.67%)	1
Vascular disorders
Deep Vein Thrombosis †	1/150 (0.67%)	1
Femoral Artery Dissection †	1/150 (0.67%)	1
Hypotension †	7/150 (4.67%)	7
Peripheral Artery Stenosis †	1/150 (0.67%)	1
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Medtronic TAVR Systems
	Affected / at Risk (%)	# Events
Total	120/150 (80.00%)
Blood and lymphatic system disorders
Anemia †	10/150 (6.67%)	10
Thrombocytopenia †	13/150 (8.67%)	13
Cardiac disorders
Atrioventricular Block First Degree †	18/150 (12.00%)	19
Bundle Branch Block Left †	51/150 (34.00%)	51
Bundle Branch Block Right †	9/150 (6.00%)	9
Injury, poisoning and procedural complications
Anemia Postoperative †	8/150 (5.33%)	8
Vascular disorders
Hypertension †	11/150 (7.33%)	11
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Within 60 days of receipt Medtronic (MDT) will verify presence of Confidential Information (CI) & won't censor or interfere with presentation/conclusions except to protect CI (other than Study Data) & its rights in patentable or copyrightable materials, & check technical accuracy of MDT data. If told by MDT that Publication contains CI or technical errors of MDT data, PI will make requested changes before publishing/presenting. PI will delay publication up to 90 more days, if requested.

Results Point of Contact

• Name/Title: Hatice Bilgic Lim, PhD; Principal Clinical Research Specialist
• Organization: Medtronic Coronary and Structural Heart Clinical
• Phone: 763-526-1018
• EMail: hatice.bilgic.lim@medtronic.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Forrest JK, Ramlawi B, Deeb GM, Zahr F, Song HK, Kleiman NS, Chetcuti SJ, Michelena HI, Mangi AA, Skiles JA, Huang J, Popma JJ, Reardon MJ. Transcatheter Aortic Valve Replacement in Low-risk Patients With Bicuspid Aortic Valve Stenosis. JAMA Cardiol. 2021 Jan 1;6(1):50-57. doi: 10.1001/jamacardio.2020.4738.

• Responsible Party: Medtronic Cardiovascular
• ClinicalTrials.gov Identifier: NCT03635424
• Other Study ID Numbers: 10790330DOC
• First Submitted: July 31, 2018
• First Posted: August 17, 2018
• Results First Submitted: October 29, 2020
• Results First Posted: December 21, 2020
• Last Update Posted: May 2, 2024